UMIN-CTR Clinical Trial

Basic information
Public title	Usefullness of infliximab as a second tumor necrosis factor inhibitor in patients with rheumatoid arthritis with inadequate response to tumor necrosis factor inhibitor
Acronym	IFX-2nd
Scientific Title	Usefullness of infliximab as a second tumor necrosis factor inhibitor in patients with rheumatoid arthritis with inadequate response to tumor necrosis factor inhibitor
Scientific Title:Acronym	IFX-2nd
Region	Japan

Condition
Condition	rheumatoid arthritis
Classification by specialty	Clinical immunology Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Serum tumor necrosis factor (TNF) level was reported to be relatively higher in the patients with rheumatoid arthritis (RA) especially with inadequate response to first TNF inhibitor (TNFi). For those RA patients with inadequate response to TNFi it was reported that increasing dose of TNFi was required in order to reduce disease activity of RA. Because increasing dose or shorter interval of administration was approved for the use of infliximab (IFX), IFX seems ideal for the purpose of use in such cases. In this study we investigate the better efficacy of increasing dose of IFX than ordinary dose from the start in patients with RA with inadequate response to TNFi except IFX.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase IV

Assessment
Primary outcomes	Evaluation of disease activity score 28-CRP (DAS28-CRP) at 30 weeks
Key secondary outcomes	1) Evaluation of structural damage by modified total Sharp score at 54 weeks 2) Evaluation of synovitis by ultrasound at 54 weeks 3) Evaluation of blood test at 54 weeks 4) Evaluation of modified Health Assessment Questionnaire at 54 weeks 5) Adverse reaction at 54 weeks 6) Evaluation of DAS28-CRP at 30 weeks

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Dose comparison
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	administrated with 3mg/kg of IFX
Interventions/Control_2	administrated with 10mg/kg of IFX
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	85 years-old >
Gender	Male and Female
Key inclusion criteria	1) Out-patients who is planned to receive IFX with active moderate-to-severe RA with inadequate response to adalimumab, etanercept, golimumab or certolizumab pegol 2) The patients who administrated with methotrexate 3) Patients must have taken stable dose of NSAID, glucocorticoid, or conventional synthetic disease modifying anti rheumatic drugs 4) Aged 20 years or older and less than 85 years old 5) The patients who provided their informed consent to participate in the study
Key exclusion criteria	1) The patients with inadequate response to IFX after 6-weekloading administration 2) The patients with arthritic condition other than Ra 3) The patients who is planned to undergo surgery 4) Patients with allergy to IFX 5) Patients who is pregnant or lactate 6)patients who have received IFX administration 7) Those who are not approved to be eligible to this study by corresponding researcher or co-researchers
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Kentaro Middle name Last name Inui
Organization	Osaka City University Graduate School of Medicine
Division name	Orthopaedic Surgery
Zip code	545-8585
Address	1-4-3 Asahi-machi, Abeno-ku, Osaka545-8585, Japan
TEL	06-6645-3851
Email	inuken@med.osaka-cu.ac.jp

Public contact
Name of contact person	1st name Kentaro Middle name Last name Inui
Organization	Osaka City University Graduate School of Medicine
Division name	Orthopaedic Surgery
Zip code	545-8585
Address	1-4-3 Asahi-machi, Abeno-ku, Osaka545-8585, Japan
TEL	06-6645-3851
Homepage URL
Email	inuken@med.osaka-cu.ac.jp

Sponsor
Institute	Osaka City University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Osaka City University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Osaka City University Hospital Certified Review Board
Address	1-2-7-601 Asahi-machi, Abeno-ku, Osaka
Tel	06-6645-3456
Email	ethics@med.osaka-cu.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2016 Year 07 Month 15 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	1
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 07 Month 01 Day
Date of IRB	2016 Year 07 Month 01 Day
Anticipated trial start date	2016 Year 07 Month 01 Day
Last follow-up date	2020 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 07 Month 04 Day
Last modified on	2019 Year 07 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026517